Takeda Pharmaceuticals North America stepped up competition in the lucrative market for combination oral antidiabetic agents yesterday after winning approval for Duetact in the USA.
The US Food and Drug Administration (FDA) approved Duetact - which combines Takeda’s Actos (pioglitazone HCl) and the generically-available glimepiride in a single pill - for the treatment of type 2 diabetes yesterday. The company says it intends to launch the product ‘later this year’.
Takeda is competing in this sector with GlaxoSmithKline’s whose own Avandia (rosiglitazone) drug has been combined with glimepiride as Avaglim, a product that was cleared in Europe in June but has not yet received the go-ahead in the USA.
Both Takeda and GSK also sell combinations of their glitazone drugs with another diabetes medication, metformin, as ActoPlus and Avandamet, respectively. Takeda’s product was recommended for approval under the Competact trade name in June.
Meanwhile, Takeda also started Phase III trials of a fixed-dose combination of Actos and TAK-536, an investigational angiotensin receptor blocker that is also being developed as a monotherapy for high blood pressure. The combination should offer multiple benefits to patients with diabetes, who often go on to develop cardiovascular disease, said Takeda.
Combining these medications may provide patients with an easier way to take the two drugs, as diabetic patients are often prescribed multiple medications to help manage the disease.
Duetact will be available in two commonly used dosages of pioglitazone and glimepiride to be taken once daily - 30mg/2mg and 30mg/4mg.
Tavocept fails at Phase III
Meanwhile, Takeda looks set to drop development of Tavocept (BNP7787), a drug designed to prevent the side effects of cancer chemotherapy lcensed from BioNumerik Pharmaceuticals, after disappointing results in two Phase II trials.
Tavocept was in testing to see if it could prevent common and serious side effects, particularly nerve and kidney damage that can be associated with taxane and platinum drugs. BioNumerik said subgroup analyses from the study suggest some efficacy and that additional clinical trials should be considered.